How Long Does It Take to Put Together a New Drug Application after A?

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How long does it take to put together a New Drug Application after a phase 3 drug trial?

It is IMPOSSIBLE to answer your question for MANY reasons. NOTABLE amongst them. does the drug WORK without killing the patients? Keep in mind that the clinical trials are for two purposes. to study the EFFECTIVENESS of the drug in treating some specific disorder or condition and to study the SAFETY of the drug when used in the dosages necessary to accomplish the first goal. BOTH are subjective. Very few drugs, if any, drugs are 100% effective and virtually NO DRUG ANYWHERE, of ANY KIND, is 100% safe. Effectiveness is fairly forthright and the Federal Food, Drug and Cosmetic Act does NOT require that a new drug be more effective (or even “as” effective) as drugs already on the market; SAFETY is often a complex risk/benefit analysis. WHAT extent and frequency of adverse events is acceptable for the expected therapeutic benefit? Obviously, adverse events are a lot more “acceptable” for drugs that offer hope of benefit in treating horrrendous and/or fatal diseases and conditions. FDA reviewers do NOT have an easy task!

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Many drugs have serious potential risks and some have NO potential risks at all. If a drug has very little or NO potential risk at all, the drug cannot be evaluated for safety or effectiveness. A “small potential” or “very low” risk drug cannot be evaluated at all. FDA reviewers cannot consider risk factors for efficacy or safety in their reviews. They must make decisions based solely on data that is available in the clinical trial data file, the data file they have examined (which does contain a lot more data than the “other” data). What are the limitations of the review process? The review process is very different for different drugs. Most drugs are reviewed by FDA (the Food and Drug Administration) under the Investigational New Drug (IND) designation. Some drugs are reviewed under the remarketing new drug designation (POND) designation. Some drugs are reviewed under the “new drug application”.